Trial reportBMJ open2024
Impact of dexmedetomidine-ropivacaine versus sufentanil-ropivacaine combination for epidural labour analgesia on neonatal outcomes: a pilot randomised clinical trial.
Trial report in BMJ open, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 5 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Effect of Dexmedetomidine Plus Ropivacaine Versus Sufentanil Plus Ropivacaine for Epidural Labor Analgesia on Neonatal Outcomes: a Pilot Randomized Trial
Dexmedetomidine-esketamine-ropivacaine Versus Sufentanil-ropivacaine Combination for Epidural Labor Analgesia and Neonatal Outcomes: a Pilot Randomized Trial
Who cites it
5 citing papers in PubMed.
- Optimal Interval for Intermittent Epidural Bolus with Ropivacaine-Dexmedetomidine Using the Epidural Dural Puncture Technique for Labour Analgesia: A Coin Bias Up-Down Study.Drug design, development and therapy · 2026Trial
- Determining the Optimal Volume of Ropivacaine Combined with Dexmedetomidine for Programmed Intermittent Epidural Bolus in Labor Analgesia: A Randomized Dose-Response Study.Drug design, development and therapy · 2026Trial
- Safety and Efficacy of Dexmedetomidine as an Adjuvant in Epidural Anesthesia for Labor Analgesia: A Narrative Review.Medical sciences (Basel, Switzerland) · 2026Review
- Comparison of continuous epidural analgesia, traditional combined spinal-epidural, and modified combined spinal-epidural for labor analgesia: a multicenter retrospective cohort study.Frontiers in medicine · 2026Article
- A Study on the ED90 of Esketamine Combined with Ropivacaine for Early Epidural Analgesia During the First Stage of Labor in Nulliparous Women: A Randomized, Sequential Dose-Finding Trial.International journal of women's health · 2026Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
5 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectiveTo investigate the impact of dexmedetomidine-ropivacaine combination versus sufentanil-ropivacaine combination for epidural labour analgesia on neonatal and maternal outcomes and test the feasibility of a future large, randomised trial.
designA randomised, double-blind, pilot clinical trial from 16 March 2023 to 15 June 2023.
settingA tertiary-care hospital in Beijing, China.
participants200 women aged≥18 years who had full-term single pregnancy and were scheduled for vaginal delivery with epidural analgesia.
interventionsEligible participants were randomly assigned in a 1:1 ratio to receive self-controlled epidural labour analgesia using ropivacaine supplemented with either dexmedetomidine (0.45 µg/mL for induction and 0.36 µg/mL for maintenance) or sufentanil (0.45 µg/mL for induction and 0.36 µg/mL for maintenance). MAIN OUTCOMES AND MEASURES: The primary endpoint was a composite of neonatal morbidity, including 1- or 5 min Apgar score<7, umbilical artery PH<7.1, requirement for immediate assisted ventilation and admission to neonatal ward or intensive care unit within 24 hours. Secondary and other endpoints included effect of analgesia and occurrence of adverse events. The feasibility of implementing the protocol was evaluated.
resultsAll 200 women were included in the intention-to-treat analysis. Composite neonatal morbidity occurred in 14.0% (14/100) of women with dexmedetomidine versus 17.0% (17/100) of women with sufentanil: relative risk 0.82, 95% CI 0.43 to 1.58. Women in the dexmedetomidine group had a comparable area under curve of pain intensity (median difference -2.0 point⋅h, 95% CI -9.9 to 5.9, p=0.638), required more self-controlled boluses (median difference two boluses, 95% CI 0 to 3, p=0.040) and epidural analgesics (median difference 17 mL, 95% CI 4 to 29, p=0.007), and experienced less pruritus (0.0% (0/100) vs 30.0% (30/100), p<0.001) but more lower limb weakness (13.0% (13/100) vs 1.0% (1/100), p<0.001). Recruitment rate was satisfactory (87.7%); the protocol was well accepted by anaesthesiologists and nurses.
conclusionsCompared with sufentanil-ropivacaine combination, use of dexmedetomidine-ropivacaine combination for epidural labour analgesia was associated with a 18% decrease in composite neonatal endpoint and deserve further investigation. The dexmedetomidine-ropivacaine combination provided comparable analgesia but increased mild motor block. The conduct of a large, randomised trial using same protocol requires careful re-evaluation. TRIAL REGISTRATION NUMBER: NCT05698407.
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